J&J & Glaxo's Jucala Approval Puts Spotlight On HIV Space

Johnson & Johnson (NYSE:JNJ) and partner GlaxoSmithKline (NYSE:GSK) recently announced FDA approval for Juluca — a combination of Glaxo’s Tivicay/rilpivirine and J&J’s Edurant/dolutegravir into a single tablet — for the treatment of HIV

Most medicines for HIV treatment are made up of three or more antiretroviral drugs. Juluca is the first two-drug regimen that reduces the number of medicines HIV patients take without compromising on the efficacy of a conventional three-drug regimen. The approval of Juluca has shifted investor focus to the HIV disease space. Let’s see how companies are trying to tap into this huge market.

A Note on HIV

HIV stands for human immunodeficiency virus. It weakens the immune system by destroying cells that fight diseases and infections and can eventually lead to AIDS (acquired immunodeficiency syndrome). Medicines for the treatment of HIV are called antiretroviral therapy (ART) that slow or put a check on the progression of the virus.

Globally, about 36.7 million people were living with HIV/AIDS at the end of 2016. Of the total, 2.1 million were children (less than 15 years old).

Despite improved medical understanding of HIV and its prevention and treatment as well as significant efforts made by leading government and medical bodies, HIV and AIDS still has no cure. Notably, 1 million people died of AIDS-related illnesses in 2016, reaching the total number since the start of the epidemic to 35.0 million.

Companies Developing HIV Drugs

Marketed Therapies for HIV

Several pharmaceutical companies are marketing drugs/therapies to treat HIV. Gilead (NASDAQ:GILD) is a dominant player in the HIV market with an impressive portfolio. The company was the first to introduce a single-tablet regimen (STR) for the treatment of HIV — Atripla. Gilead’s other STRs for HIV include Complera/Eviplera and Stribild. Its TAF-based product Genvoya is a bestseller, surpassing both Truvada and Atripla since fourth-quarter 2016.

Another company, GlaxoSmithKline has a long-standing commitment to HIV and infectious diseases. The company had developed the widely used antibiotic amoxycillin around 40 years ago, and developed the first medicines approved to treat HIV (AZT). The company’s other marketed HIV drugs include Triumeq and Tivicay.Other popular marketed HIV drugs are AbbVie’s (NYSE:ABBV) Kaletra and Merck’s (NYSE:MRK) Isentress.

Another pharmaceutical company Mylan (NASDAQ:MYL) has received a tentative approval from the FDA for its combination tablet, comprising efavirenz, lamivudine and tenofovir disoproxil fumarate, to treat HIV.

What’s in the Pipeline?

Companies are working on developing new drugs to treat, prevent and possibly cure HIV. Scientists are exploring new treatment paradigms like two-drug regimens, making therapies/drugs with improved safety profiles and new mechanisms of actions.

Gilead’s STR bictegravir for HIV treatment is under priority review in the United States. The FDA is expected to announce its decision next February. The STR is a fixed-dose combination of bictegravir, an INSTI, and emtricitabine/tenofovir alafenamide (FTC/TAF), a dual-NRTI backbone.

Merck is developing an investigational non-nucleoside reverse transcriptase inhibitor MK-1439, doravirine for HIV -1 infection and plans tofile regulatory applications for fixed-dose combination of the same,both as a single-entity tablet and a fixed-dose combination tabletconsisting of fixed-dose combination of doravirine (DOR), lamivudine (3TC), and tenofovir disoproxil fumarate (TDF) n late 2017.

Glaxo is also developing two drug regimens are dolutegravir + lamivudineand cabotegravir + rilpivirine.

As an increasing number of companies are developing drugs to treat this life threatening disease, competition has intensified manifold in the space. Meanwhile, it is to be seen how Juluca fares in the market.

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